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NCT01103492 · ClinicalTrials.gov registry record · NA
Treatment of Hemorrhagic Radiation Proctitis Using the Halo System
A NA study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT01103492 is a NA study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 1 participants.
The verdict
NCT01103492, a NA study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
This study involves evaluating a procedure in which the study device, the HALO90 Ablation catheter, is used to heat a thin layer of tissue lining the rectum using radiofrequency (RF) energy in subjects suffering from radiation proctitis (acute inflammation of the inner lining of the rectum caused by the side effects of radiation treatments that can lead to bleeding). In medical procedures, the RF energy used with this device, has been historically used in shrinking or removing soft-tissue, for surgical cutting, and for stopping bleeding. The device is cleared by the Food and Drug Administration (FDA) for use in coagulation (to assit with stoping bleeding and clotting of blood) of tissue within the digestive tract. The device has been used in areas outside the esophagus (inner lining of the throat), including the rectum to treat radiation proctitis. The stoppage of bleeding of radiation proctitis, using the HALO device, may be one method to control the bleeding. The purpose of this study is to evaluate the effectiveness and record the results of treatment of radiation proctitis using the HALO device.
Interventions
- DEVICE HALO90 Ablation catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2008-07 |
| Est. Completion | 2009-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01103492
The ClinicalTrials.gov registry entry for NCT01103492 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HALO90 Ablation catheter is the first listed.
NCT01103492 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01103492 about?
NCT01103492 is a clinical study titled "Treatment of Hemorrhagic Radiation Proctitis Using the Halo System". This study involves evaluating a procedure in which the study device, the HALO90 Ablation catheter, is used to heat a thin layer of tissue lining the rectum using radiofrequency (RF) energy in subjects suffering from radiation proctitis (acute inflammation of the inner lining of the rectum caused by...
What is the current status of trial NCT01103492?
This trial is currently completed. It is a NA study. The enrollment target is 1 participants. The study started on 2008-07. Estimated completion is 2009-06.
What interventions are being tested in trial NCT01103492?
The interventions under investigation include: HALO90 Ablation catheter (DEVICE).
Who is sponsoring clinical trial NCT01103492?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
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